510(k) · Cleared
Recalled · 2007Syngo US Workplace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions · LLZ System, Image Processing, Radiological
Cleared on Apr 28, 2006 as substantially equivalent to K052410 (Siemens Medical Solutions USA, Inc., 2005) and 13 other predicates after a 17-day review. Its family tree reaches back 7 generations to 1995. 97 later devices descend from it. It has been recalled once.
- Decided
- Apr 28, 2006
- Review
- 17 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 15
Its longest line of descent runs back 7 generations to K935595 (1995). 47 ancestors in all, the oldest K891449 (1989). 97 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 6 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 5 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 4 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 3 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 2 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 1 generation backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- This deviceK060992 Syngo US WorkplaceSiemens Medical Solutions · 2006
- Descendant · cites it directly · 95 of its ownK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 92 of its ownK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- Descendant · 3 generations on · 91 of its ownK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 45 of its ownK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
- Descendant · 5 generations on · 44 of its ownK181264 QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018
Showing 5 of 97 descendants. See all descendants
Descendants cleared per year
2008high 17 (2025) · low 0 (2010)2026
Most influential descendants
Showing 5 of 97 · See all- K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009 · cites it directly95descendants
- K130159Qlab Quantification Software Heart ModelPhilips Health Care · 2013 · 2 generations on92descendants
- K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · 3 generations on91descendants
- K171314QLAB Advanced Quantification SoftwarePhilips Health Care · 2017 · 4 generations on45descendants
- K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018 · 5 generations on44descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −6 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −5 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −4 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −3 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −2 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −1 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| 0 (this device) | K060992 | Syngo US Workplace | Siemens Medical Solutions | 2006 | — |
| +1 | K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| +3 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
| +4 | K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017 | — |
| +5 | K181264 | QLAB Advanced Quantification Software | Philips Ultrasound, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 11 | 0 |
| 2021 | 7 | 0 |
| 2022 | 11 | 0 |
| 2023 | 8 | 0 |
| 2024 | 12 | 0 |
| 2025 | 17 | 0 |
| 2026 | 14 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (15)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052410 | Acuson Sequoia Ultrasound SystemSummary page 1…Picture Archiving and Communications System 21 CIFR# 892.2050 Product Code 90-LLZ7 3. Predicate Devices: Siemens Ultrasound Systems (K052410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K… | 2005 |
| * | K051139 | Acuson Sequoia Diagnostic Ultrasound SystemSummary page 1…cture Archiving and Communications System 21 CIFR# 892.2050 Product Code 90-LLZ7 3. Predicate Devices: Siemens Ultrasound Systems (K052410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K 022896) a… | 2005 |
| * | K041319 | Sequoia Diagnostic Ultrasound SystemSummary page 1…hiving and Communications System 21 CIFR# 892.2050 Product Code 90-LLZ7 3. Predicate Devices: Siemens Ultrasound Systems (K052410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K 022896) and the Tom… | 2004 |
| Kept off the family tree | K032144 | FDA’s K032144 is Perifix Catheter Connector Our reading of the summary gave K032144, FDA’s number for Perifix Catheter Connector (B.Braun Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Siemens Ultrasound Systems”. Kept off the family tree. Summary page 1…Communications System 21 CIFR# 892.2050 Product Code 90-LLZ7 3. Predicate Devices: Siemens Ultrasound Systems (K052410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K 022896) and the TomTec; Imag… | 2003 |
| * | K022567 | Sequoia Signature II Diagnostic Ultrasound SystemSummary page 1…stem 21 CIFR# 892.2050 Product Code 90-LLZ7 3. Predicate Devices: Siemens Ultrasound Systems (K052410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K 022896) and the TomTec; Image Arena (K040546)… | 2002 |
| * | K050034 | Sonoline Antares Diagnostic Ultrasound SystemSummary page 1…21 CIFR# 892.2050 Product Code 90-LLZ7 3. Predicate Devices: Siemens Ultrasound Systems (K052410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K 022896) and the TomTec; Image Arena (K040546) 4.… | 2005 |
| * | K033196 | Sonoline Antares with Clarify VESummary page 1…# 892.2050 Product Code 90-LLZ7 3. Predicate Devices: Siemens Ultrasound Systems (K052410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K 022896) and the TomTec; Image Arena (K040546) 4. Device D… | 2003 |
| * | K023720 | Sonoline Antares Ultrasound SystemSummary page 1…0 Product Code 90-LLZ7 3. Predicate Devices: Siemens Ultrasound Systems (K052410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K 022896) and the TomTec; Image Arena (K040546) 4. Device Descriptio… | 2002 |
| * | K021497 | Cypress Ultrasound SystemSummary page 1…Product Code 90-LLZ7 3. Predicate Devices: Siemens Ultrasound Systems (K052410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K 022896) and the TomTec; Image Arena (K040546) 4. Device Description:… | 2002 |
| * | K010950 | Cypress SystemSummary page 1…Code 90-LLZ7 3. Predicate Devices: Siemens Ultrasound Systems (K052410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K 022896) and the TomTec; Image Arena (K040546) 4. Device Description: The sy… | 2001 |
| * | K891449 | Sonoline CFSummary page 1…LLZ7 3. Predicate Devices: Siemens Ultrasound Systems (K052410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K 022896) and the TomTec; Image Arena (K040546) 4. Device Description: The syngo US Wo… | 1989 |
| * | K904017 | Siemens Sonoline SI-450, OB/Gyn,Ent,Dental DevicesSummary page 1…Predicate Devices: Siemens Ultrasound Systems (K052410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K 022896) and the TomTec; Image Arena (K040546) 4. Device Description: The syngo US Workplace i… | 1991 |
| * | K052895 | Foursight Viewtool Image ViewerSummary page 1…vices: Siemens Ultrasound Systems (K052410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K 022896) and the TomTec; Image Arena (K040546) 4. Device Description: The syngo US Workplace is used to view ima… | 2005 |
| * | K022896 | CSV12 Software ViewerSummary page 1…Siemens Ultrasound Systems (K052410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K 022896) and the TomTec; Image Arena (K040546) 4. Device Description: The syngo US Workplace is used to view images, to st… | 2002 |
| * | K040546 | Image-Arena and Research-Arena ApplicationsSummary page 1…410, K051139, K041 319, K032144, K022567,K050034, K033196, K023720, K021497, K010950, K891449, K904017, K052895, K 022896) and the TomTec; Image Arena (K040546) 4. Device Description: The syngo US Workplace is used to view images, to store and print images, and to… | 2004 |
What descends from it? (97)
See all 972 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 6, 2007 | Not classified | Z-1138-2008 | Software design | Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 8 of the 47 ancestors have a recall of any class.
- Of its descendants, K091286 (Siemens Medical Solutions USA, Inc., 2009) has gone furthest, with 95 descendants of its own.
- 6 other devices also cite its predicate K052410.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2007high 106 (2011) · low 51 (2010)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
2007high 173 (2025) · low 36 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
2007high 64 (2013) · low 2 (2019)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
2007high 15,631 (2014) · low 26 (2023)2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
syngo® US Workplace is used to view post processed ultrasound images, to store and print images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM compliant PACS system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060992 · printed Nov 3, 2026
Cite this page
510(k) Report. “K060992: Syngo US Workplace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K060992
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026